西地那非治疗小儿高原性心脏病合并重度肺动脉高压疗效和安全性的初步评估

Efficacy and safety of sildenafil in the treatment of high altitude heart disease associated with severe pulmonary arterial hypertension in children：a preliminary evaluation

摘要:

目的 观察西地那非治疗对小儿高原性心脏病合并重度肺动脉高压（PAH）患儿的临床疗效和安全性。方法 选择2011 年1 月至2013 年10 月连续转入重症监护病房的小儿高原性心脏病合并重度PAH 患儿50 例（年龄2 个月至2 岁），随机分为观察组和对照组。对照组给予常规方法治疗，观察组在此基础上给予口服西地那非治疗（剂量为每日1 mg/kg，分3 次口服，连服7~10 d）。记录治疗前后血流动力学改变、血气、血常规和血生化等的变化。结果 治疗后观察组患儿平均肺动脉压的下降程度、动脉血氧分压、心输出量、心脏指数及氧合指数的上升程度均明显优于对照组（P<0.05）。观察组平均体动脉压、血常规、血生化指标等均无明显变化（P>0.05），未发现明显不良反应。结论 西地那非治疗小儿高原性心脏病合并重度PAH，可有效降低肺动脉压力，改善患儿的心功能，且无不良反应，初步安全性评估良好。

Abstract:

Objective To observe the clinical efficacy and safety of sildenafil in the treatment of high altitude heart disease associated with severe pulmonary arterial hypertension (PAH) in children. Methods Fifty children (aged 2 months to 2 years) with high altitude heart disease associated with severe PAH, who were continuously transferred to the Intensive Care Unit between January 2011 and October 2013, were randomly assigned to observation and control groups. The control group was given conventional treatment, while the observation group received oral sildenafil [1 mg/(kg·d)] three times daily for 7-10 days in addition to the conventional treatment. Before and after treatment, hemodynamics, blood gas, routine blood parameters, and blood biochemical parameters were recorded. Results After treatment, the observation group had a significantly higher decrease in mean pulmonary artery pressure and significantly higher increases in arterial partial pressure of oxygen, cardiac output, cardiac index, and oxygenation index compared with the control group (P<0.05). In the observation group, there were no significant changes in mean arterial pressure, routine blood parameters and blood biochemical parameters (P>0.05), and no obvious adverse reactions were found. Conclusions For children with high altitude heart disease associated with severe PAH, sildenafil can effectively reduce pulmonary artery pressure and improve cardiac function and does not cause adverse reactions. This therapy has good safety according to the preliminary evaluation.